Siemens QuikLYTE Dilution Check Recalled for Potential Result Bias
Siemens Healthcare Diagnostics is recalling QuikLYTE Dilution Check units due to a potential positive bias that could cause elevated patient results for sodium, potassium, and chloride.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the hazard is theoretical (potential for elevated patient results) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 5,981 units of the QuikLYTE Dilution Check, catalog number S640, lot number 4MD707. This product is used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems equipped with the QuikLYTE module. The units were distributed worldwide.
The recall is due to a potential positive bias in the dilution check. If the bias is greater than 1% and less than 5%, it may trigger an unnecessary dilution check correction. If this correction is not detected by quality control, it could decrease the calibration curve, leading to elevated patient results for sodium, potassium, and chloride. A bias beyond 5% would result in a dilution check failure.
Healthcare facilities using the Dimension clinical chemistry system with the QuikLYTE module should contact Siemens Healthcare Diagnostics for instructions on how to handle the affected units. The product is intended for the quantitative measurement of sodium, potassium, chloride, and total carbon dioxide in human serum and heparinized plasma, as well as sodium, potassium, and chloride in urine.
The recalled product
- Product
- QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 5,981
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number S640
- Siemens Material Number (SMN) 10444872
- Lot Number 4MD707
Distribution
Distribution scope not specified by the agency.
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